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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceIDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILIES OF PACEMAKERS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880086
Supplement NumberS101
Date Received08/30/2004
Decision Date11/22/2004
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOLLOWING: 1) A FIRMWARE MODIFICATION TO THE IDENTITY/IDENTITY ADX FAMILY OF PACEMAKERS TO CORRECT A POTENTIAL CONDITION THAT WOULD RESULT IN HARDWARE BACK-UP VVI PACING; AND 2) A COMPONENT DESIGN CHANGE TO IDENTITY/IDENTITY ADX, INFINITY AND INTEGRITY FAMILY OF PACEMAKERS MODIFYING THE PRINTED CIRCUIT BOARD USED TO CONNECT THE FEEDTHROUGH TO THE PACEMAKER CIRCUITRY.
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